Director, Regulatory Labeling Operations

Role Summary

Director, Regulatory Labeling Operations

Responsibilities

• Oversee Regulatory Labeling Operations in the development, revision, and approval of packaging component artworks for marketed products and products in full development; oversee submission-ready labeling documents.
• Manage interface with Manufacturing/Supply Chain, Regulatory Operations, and labeling vendors; lead or support labeling content and/or artwork system development and implementation; support labeling SOPs or work instructions.
• Lead Regulatory Labeling Operations in development, revision, and approval of packaging component artworks (carton, container labeling, printed package insert) for full development and marketed products.
• Advise Packaging Teams to ensure packaging content and artworks comply with internal labeling policies, SOPs, and worldwide regulations.
• Manage Regulatory Labeling Operations Group; provide training and guidance for direct reports.
• Manage relationships with internal stakeholders and labeling vendors (SPL, translations, readability, QC tool).
• Provide labeling expertise to novel packaging design initiatives.
• Collaborate to develop and implement labeling content and/or artwork management system solutions.
• Support operational labeling deliverables including SPL, EMA translations/linguistic reviews, submission-ready labeling documents, proofreading/QC, and labeling contributions to periodic reports.
• Monitor worldwide regulatory changes pertaining to labeling.
• Support creation or revision of labeling SOPs or work instructions.

Qualifications

• Bachelor's degree (BS) from an accredited college or university, preferably in Health/Science, or 10+ years of industry experience.
• In-depth knowledge of worldwide regulatory agencies, industry practice, packaging manufacturing, and the drug development process; familiarity with FDA, EMEA, and international packaging regulations for biologic and combination products.
• 10-15+ years of biotech or pharma industry experience in regulatory labeling and packaging, with some management experience.
• Experience implementing new corporate labeling and/or artwork systems.
• Experience managing labeling process initiatives.
• Ability to lead/advice cross-functional packaging teams to navigate labeling issues, develop action plans, and resolve complex issues.
• Ability to work independently, use judgment, and escalate problems appropriately.
• Ability to manage multiple projects and prioritize work for self and direct reports.
• Attention to detail and strong word processing and organizational skills.

Skills

• Regulatory labeling knowledge
• Packaging artwork development and management
• Cross-functional team leadership
• Project prioritization and multitasking
• Vendor relationship management
• Documentation and SOP development

Education

• Bachelor's degree in Health/Science or equivalent industry experience

Additional Requirements

• None beyond role responsibilities and qualifications listed.